This first-of-its-kind study evaluated the impact of e-cigarette vapor, with and without nicotine, on the risks of respiratory and cardiovascular disease in a mouse model.

These results add to the existing evidence that switching smokers to smoke-free products, which can deliver nicotine with significantly lower levels of toxicants, can be part of a successful tobacco harm reduction strategy for adult smokers worldwide.

Annual Society of Toxicology Meeting in Baltimore. The study demonstrates that after 6 months, e-cigarette vapors with and without nicotine induced a significantly lower biological responses associated with cardiovascular and pulmonary diseases than cigarette smoke. The study, conducted in collaboration with Altria Group, Inc., assessed the biological response of mice exposed to e-cigarette vapors compared with that of exposure to cigarette smoke.

According to the World Health Organization, there are more than 1 billion people worldwide who smoke cigarettes and will continue to smoke in the foreseeable future. Tobacco harm reduction can play an important role by supplementing existing tobacco control strategies to help reduce the risk of smoking-related diseases. For harm reduction to be successful, current adult smokers need access to smoke-free products that deliver nicotine but with significantly lower levels of toxicants than cigarettes.

“These results are a powerful addition to the evidence showing that switching to e-cigarettes is a much better choice than continuing to smoke,” said Dr. Julia Hoeng, PMI’s Director of Systems Toxicology. “This study truly is a landmark study, not just demonstrating the reduced toxicity and disease risk between e-cigarettes and cigarettes but also evaluating the role of nicotine and flavors.”

Background

The combustion of tobacco produces over 6,000 chemicals, of which almost 100 are harmful or potentially harmful. The overwhelming scientific evidence links the exposure to these chemicals, rather than nicotine, as the primary cause of smoking-related disease. Therefore, in recent years, e-cigarettes have been gaining popularity as a potential alternative to cigarettes. Currently, however, there are limited data on the long-term disease risk profile of e-cigarettes or their components compared with that of cigarette smoke. In general, e-cigarettes consist of aerosol formers (propylene glycol [PG] and/or vegetable glycerin [VG]), nicotine, and flavor ingredients. Therefore the study is relevant for products that contain these components. In contrast with cigarettes, e-cigarettes deliver nicotine without the smoke constituents that arise from the combustion of tobacco.

About the Study

This ApoE-/- mouse study was a 6-month inhalation study designed to assess the impact of exposure to e-cigarette vapor (with and without nicotine and flavor) on the respiratory and cardiovascular systems. Female ApoE-/- mice were exposed to air, cigarette smoke, or 3 formulations of e-cigarette vapors (CARRIER: PG/VG/water; BASE: CARRIER plus 4% nicotine; TEST: BASE plus flavors) for 3 hours/day, 5 days/week for 6 months via a whole-body inhalation system. The study measured a number of disease endpoints, and the results indicate that after 6 months, e-cigarette vapor with and without nicotine and flavor:

Resulted in lower levels of lung inflammation, structural damage, and molecular changes in the lungs and induced lower atherosclerotic plaque formation and molecular changes in aorta and heart tissue compared to cigarette smoke.

The study also detected an effect of nicotine on pulse wave velocity (an expected effect of nicotine); however, when compared with cigarettes, the effect is significantly less for e-cigarette exposures (with and without nicotine).

The full results of this study will be submitted for publication in a peer-reviewed journal.

About PMI’s Research

These results contribute to the totality of evidence on smoke-free products and were produced as part of PMI’s extensive research and assessment program. This program is inspired by the well-recognized practices of the pharmaceutical industry and in line with the draft guidance of the U.S. FDA for Modified Risk Tobacco Product Applications. Over 430 PMI R&D experts are working to develop and assess new smoke-free products and have published over 350 peer-reviewed scientific publications and book chapters to date. PMI has spent more than USD 6 billion to develop, substantiate, and build manufacturing capacity for a wide portfolio of smoke-free products.

Philip Morris International: Building a Smoke-Free Future

Philip Morris International (PMI) is leading a transformation in the tobacco industry to create a smoke-free future and ultimately replace cigarettes with smoke-free products to the benefit of adults who would otherwise continue to smoke, society, the company and its shareholders. PMI is a leading international tobacco company engaged in the manufacture and sale of cigarettes, smoke-free products and associated electronic devices and accessories, and other nicotine-containing products in markets outside the U.S. PMI is building a future on a new category of smoke-free products that, while not risk-free, are a much better choice than continuing to smoke. Through multidisciplinary capabilities in product development, state-of-the-art facilities and scientific substantiation, PMI aims to ensure that its smoke-free products meet adult consumer preferences and rigorous regulatory requirements. PMI's smoke-free IQOS product portfolio includes heated tobacco and nicotine-containing vapor products. As of December 31, 2018, PMI estimates that approximately 6.6 million adult smokers around the world have already stopped smoking and switched to PMI’s heated tobacco product, which is currently available for sale in 44 markets in key cities or nationwide under the IQOS brand. For more information, see our PMI and PMIScience websites.